Phase I Study of Concomitant Pemetrexed and CDDP Plus Radiation Therapy in Patients With Locally Advanced or Metastatic Esophageal or Gastroesophageal (GEJ) Carcinomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The maximum tolerated dose (MTD) of pemetrexed
研究概览
简要总结
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin may make tumor cells more sensitive to radiation therapy. Giving pemetrexed together with cisplatin and radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when given together with cisplatin and radiation therapy in treating patients with stage III or stage IV esophageal cancer or gastroesophageal junction cancer.
详细描述
OBJECTIVES:
Primary
- To establish the maximum tolerated dose of pemetrexed disodium in combination with cisplatin and standard-dose radiotherapy in patients with stage III or IV esophageal or gastroesophageal junction carcinoma.
Secondary
- To specifically characterize the toxicity profile of this regimen.
- To investigate, preliminarily, the anti-tumor activity of this regimen, as measured by standard response criteria (RECIST criteria), in patients with measurable disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pemetrexed, Cisplatin, Radiation Therapy
Concomitant Pemetrexed and CDDP Plus Radiation Therapy
干预措施: cisplatin (Drug)
Pemetrexed, Cisplatin, Radiation Therapy
Concomitant Pemetrexed and CDDP Plus Radiation Therapy
干预措施: Pemetrexed (Drug)
Pemetrexed, Cisplatin, Radiation Therapy
Concomitant Pemetrexed and CDDP Plus Radiation Therapy
干预措施: radiation therapy (Radiation)
结局指标
主要结局
The maximum tolerated dose (MTD) of pemetrexed
时间窗: 6 months
次要结局
- Toxicity profile(12 months)
- Response (complete response, partial response, progressive disease, and stable disease) as measured by RECIST criteria(12 months)